Effect of Single Dose of 2L PEG on Bowel Preparation in Average-risk Patients Undergoing Colonoscopy

NCT ID: NCT02998255

Last Updated: 2017-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 940 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-08-31

Brief Summary

Adequate quality of bowel preparation(BP) is important for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG still results in lower compliance to the regime and increased cost.

Some high risk factors for inadequate BP have been identified, including old age, constipation, diabetes, the use of narcotics and prior history of inadequate BP. For average-risk patients without the high risk factors, the procedure of BP could be easier. In the previous study, with the use of single dose of 2L PEG, more than 90% of average-risk patients achieved adequate BP. Here investigators hypothesized that compared with the standard split dose of 4L PEG, single dose of 2L PEG may be not inferior in BP quality while may be accompanied with better tolerability.

Conditions

Health Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single dose of 2L PEG

2 L of PEG solution was used on the day of colonoscopy.

Group Type: EXPERIMENTAL

Single dose of 2L PEG

Intervention Type: DRUG

Patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. Patients began to drink 2 L of PEG 4-6 hours before colonoscopy at a rate of 250 mL every 15 minutes.

Split-dose of 4L PEG

Split-dose of 4l PEG was used before and on the day of colonoscopy

Group Type: ACTIVE_COMPARATOR

Split dose of 4L PEG

Intervention Type: DRUG

All patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. the participants began to drink the first 2 L of PEG at 7:00-9:00 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.

Interventions

Single dose of 2L PEG

Patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. Patients began to drink 2 L of PEG 4-6 hours before colonoscopy at a rate of 250 mL every 15 minutes.

Intervention Type: DRUG

Split dose of 4L PEG

All patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. the participants began to drink the first 2 L of PEG at 7:00-9:00 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients undergoing colonoscopy;
• Patients with average risks for inadequate BP (Patients were identified average-risk if they did not meet any factor of the following risk factors):

• Constipation
• Diabetes
• Parkinson's disease
• History of stroke or spine cord injure
• Prior history of inadequate bowel preparation
• BMI>25
• Use of tricyclic antidepressant or narcotics

Exclusion Criteria

• History of colorectal resection;
• Suspected colonic stricture or perforation;
• Incomplete or complete bowel obstruction;
• Use of prokinetic agents or purgatives within 7 days;
• Toxic colitis or megacolon;
• Pregnancy or lactation;
• Unable to give informed consent;
• Haemodynamically unstable.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Yanglin Pan

Associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of gastroenterology, Qinghai Provincial People's Hospital

Xining, Qinghai, China

Department of gastroenterology, Shaanxi Second People's Hospital

Xi'an, Shaanxi, China

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, China

Countries

China

Other Identifiers

KY20162097-5

Identifier Type: -

Identifier Source: org_study_id